[co-authors: Juan Carlos Hernanz, Santiago Tomas]*
World Law Group member firms recently collaborated on a Global Cannabis Guide that provides a brief overview of laws and policies regarding the use of cannabis in various jurisdictions. It briefly outlines information on the most important legal issues, from relevant legislation and general information to special requirements and risks.
The guide does not claim to be comprehensive, and laws in this area are quickly evolving. In particular, it does not replace professional and detailed legal advice, as facts and circumstances vary on a case-by-case basis and country-specific regulations may change.
This chapter covers Spain. View the full guide.
SPAIN
I. Introduction
1. Identify the geographic scope and limits of your answers to the questions below.
Our outline corresponds to the Spanish jurisdiction.
II. Legislation
2. Please provide links to applicable statutes and regulations.
Cannabis in general
United Nation’s Single Convention on Narcotic Drugs, 1961 (the “Single Convention”).
Act 17/1967, of April 8, updating former norms on narcotics to adapt them to the Single Convention on Narcotic Drugs (“Act 17/1967”) .
Statute of the Spanish Agency of Medicines and Health Products, approved by Royal Decree 1275/2011 (the “Statute of the Spanish Medicines Agency”) .
Act 10/1995 of November 23, on the Criminal Code (the “Spanish Criminal Code”).
Act 4/2015, of March 30, on the Protection of Public Safety (“Act 4/2015”) .
Cannabis in foodstuffs
Royal Decree 1487/2009, of September 26, on food supplements (“RD 1487/2009”).
Regulation (EU) 2283/2015 of the European Parliament and of the Council of November 25, 2015, on novel foods, amending Regulation (EU) 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 1852/2001 (Regulation 2283/2015).
Regulation (EU) 1307/2013 of the European Parliament and of the Council of December 17, 2013, establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) 637/2008 and Council Regulation (EC) 73/2009 (“Regulation 1307/2013”).
Royal Decree 191/2011, of February 18, on the General Health Registry of Food Business Operators (RD 191/2011).
Cannabis for medicinal use
Royal Legislative Decree 1/2015, of July 24, passing the Act on Guarantees and Rational Use of Medicinal Products and Medical Devices (“RDL 1/2015”).
Royal Decree 1345/2007, of October 11, on the authorization, registry and dispensing proceedings regarding medicinal products for human use.
Cannabis in cosmetic products
Royal Decree 85/2018, of February 23, on Cosmetic Products (“RD 85/2018”).
Regulation (EC) 1223/2009 of the European Parliament and of the Council of November 30, 2009, on Cosmetic Products (Regulation 1223/2009).
A. Is there any pending legislation that could materially alter applicable statutes or regulations?
There are no pending regulations.
B. Is there any proposed legislation that could materially alter applicable statutes or regulations?
In December 2019, the European Observatory for Cannabis Consumption and Cultivation, a private organization, proposed a law to regulate the therapeutic use of the cannabis plant (other than its use in the manufacturing of authorized medicines, which is already established by the current regulations). If this regulation were passed, it would make possible the therapeutic use of cannabis in Spain, other than its incorporation as the active substance of medicines. However, this proposal has not been processed yet and it is not expected in the near future.
3. Are cannabis laws in your jurisdiction pretty well settled or are they constantly changing in material ways?
In Spain, there are very few regulations on cannabis. The ones that exist are well settled; one of the most common criticisms is that they may have become obsolete.
III. General information (e.g., governing bodies, licenses, import/export)
4. What governing body regulates/licenses or enforces activities that are allowed in your jurisdiction?
The Spanish Agency on Medicines and Medical Devices (“AEMPS”).
5. What cannabis functions are allowed in your jurisdiction? E.g., growing, processing, retailing.
In Spain, section two of Act 17/1967 defines as narcotic drugs all substances included in list I and II of the Single Convention and assigns to the State the regulation on storage and distribution of narcotic products for use by laboratories, drugstore offices, hospitals and authorized distribution centers for the manufacture of medicines.
The plant, its resin, extracts and dyeing are included in list I of the United Nation’s Single Convention, whose article 1 defines cannabis as the “flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated.”
Under sections 8, 12 and 16 of Act 17/1967, cultivation, production, storage, import, export acquisition and transit of narcotic drugs are subject to prior authorization of the relevant authorities. Currently, under section 27 of article 7 of the Statute of the Agency of Medicines, AEMPS will develop the functions and be responsible for examining and controlling licit traffic and the use of narcotics and psychotropic substances. This authorization is only granted if the purpose of the above “functions” or processes is industrial, therapeutic, scientific or educational uses that are permitted in Spain (discussed in section 6 below), or the exportation of the production to a company authorized in the country of destination.
Without authorization, all activities entailing the cultivation, production, storage import, export, acquisition and transit of narcotic drugs will be considered illegal, under article 15 of Act 17/1967.
6. What sales or use is allowed in your jurisdiction? E.g., edibles, vaping, tinctures, food additives, etc.
It is necessary to keep in mind the distinction between the parts considered a “narcotic drug” under the definition referred to in section 5 above. This distinction is relevant because the Spanish regulations only prohibit or subject to specific authorization the activities using the parts of the cannabis plant that fall under this definition.
As Act 17/1967 refers to list I of narcotic drugs of the United Nation’s Single Convention, in Spain the flowering or fruiting tops of the cannabis plant (resin not extracted), the separated resin, crude or purified, obtained from the cannabis plant and its tinctures are considered a narcotic drug. However, the seeds and leaves when not accompanied by the tops, which are expressly excluded from the scope of the Single Convention, are not considered a narcotic drug.
Activities using the parts of the plant considered a narcotic drug
(i) Recreational use: Recreational use of the parts of the plant classified as a narcotic drug is strictly forbidden.
(ii) Use as active substance for medicines: This is not prohibited, but all operations concerning medicines including narcotic drugs are subject to authorization by AEMPS. Only one medicine containing cannabis has been authorized in Spain. Additionally, only pharmaceutical companies authorized for this purpose and registered with AEMPS can manufacture, distribute and commercialize medicines incorporating narcotic drugs. These authorizations require undeniable proof and technical grounds of their effectiveness for therapeutic indications and a specific evaluation of their adverse effects.
(iii) Scientific/research uses: These uses are not forbidden, but they are subject to authorization by AEPMS (both for the use itself and for the company).
(iv) Therapeutic use (other than incorporating cannabis into a medicinal product): There is a legal gap on the therapeutic use of cannabis in Spain. Although Act 17/1967 refers to the therapeutic use of narcotic drugs and the possibility of their authorization, it defers its regulation to a further regulatory development that has never taken place. This means that all operations concerning the therapeutic use of cannabis (from the manufacturing of the products to its distribution and commercialization) would be subject to AEMPS’ authorization, although the regulations governing the basis of these authorizations and making them possible do not exist yet.
(v) Cosmetic use: The use of narcotic drugs in cosmetic products is specifically prohibited by Regulation 1223/2009. As this regulation refers to the Single Convention to define what is considered a narcotic drug for its purposes, cosmetic products using flowering or fruiting tops of the cannabis plant from which the resin has not been extracted cannot be marketed.
(vi) Use in foodstuffs (including food supplements): Not permitted. Only foodstuffs using cannabis seeds (e.g., oils or flours) of the “Cannabis sativa L” plant variety (particularly if its THC content does not exceed 0.2%) present a significant record of safe consumption, making its commercialization possible. Any other foodstuff incorporating other parts of the cannabis plant, other cannabinoids (e.g., CBD and CBG) will be considered novel foods, which, to place the product on the market legally, entails the obligation to apply to the European Commission for authorization1, proving it is safe for consumption. Thus, the commercialization of any foodstuff containing these ingredients are not currently authorized in the EU.
(vii) Industrial use: Any industrial use of the parts of the cannabis plant considered a narcotic drug is subject to prior authorization. However use of the parts of the plants for industrial purposes if the “active narcotic substance” has been previously extracted does not need authorization, as it is excluded from Act 17/1967.
(viii) Export: Exporting the parts of the cannabis plant considered a narcotic drug (or the whole plant) requires prior authorization, which is granted if it can be proved that the importer is authorized in the country of destination to carry out its activity.
1 Pursuant to Regulation 2283/2015
Activities using the parts of the plant considered a narcotic drug
Assuming the legal origin of the plant and its cultivation has been duly authorized, when required:
(i) Recreational use: The recreational use of the parts of the cannabis plant that are not considered a narcotic drug would be expressly prohibited.
(ii) Use as active substance for medicines (plants are also considered active substances for medicines): The use of the parts of the cannabis plant (that are not considered a narcotic drug) in medicines will not be subject to further requirements or obligations other than those applicable to medicines, since the product will be considered a plant-based medicine. That means that marketing authorization must be obtained
from the AEMPS or the European Medicines Agency (“EMA”) and the medicine must be manufactured by an authorized pharmaceutical company.
(iii) Scientific/research uses: The use of the parts of the cannabis plant not considered a narcotic drug for research activities is not subject to further obligations other than those applicable to research activities in each field.
(iv) Therapeutic use (other than use of cannabis in medicines): A product for therapeutic use constituted by the parts of the cannabis plant that do not constitute a narcotic drug and that are not classified as a medicine can be considered (i) an homeopathic medicine, if it is obtained through homeopathic stocks by means of a homeopathic procedure; or (ii) a traditional medicine based on plants, if it is conceived for its use without a doctor’s control, it is used externally, by inhalation or orally, and that it holds a sufficient record of traditional and safe use for at least 30 years (from which at least 15 must correspond to its use within the EU). Homeopathic medicines are subject to specific authorization procedures by the AEMPS, while traditional medicines based on plants must be registered in the corresponding AEMPS registry.
(v) Cosmetic use: A cosmetic product containing cannabis may be legal if it has been elaborated using only the parts of the cannabis plant not considered a narcotic drug (mainly the seeds or the leaves not accompanied by the tops, but also other parts if the plant resin has been extracted) and has been produced, packed and labelled according to the regulations generally applicable to cosmetic products, so it does not entail any risk for people’s health.
(vi) Use in the elaboration of foodstuffs (including food supplements): As stated above, only the foodstuffs derived from hemp seeds have a record of safe and significant consumption, enough to be considered authorized foodstuffs under Regulation 2283/2015. However, it will still be necessary to comply with general requirements and regulations on the commercialization of foodstuffs. To commercialize any foodstuff in Spain, all companies must be registered with the Health Registry of Food Business Operators, under RD 191/2011. If the products commercialized are food supplements, further requirements would apply (the obligation to submit a communication of placement in the market to the relevant authorities and to ensure compliance with the legal labelling specifications).
(vii) Industrial use: The use of the part of the cannabis plants not considered a narcotic drug for industrial purposes, or of the parts considered narcotic drugs from which the active narcotic substance has been extracted, is not subject to any specific requirements.
(viii) Export: Exporting the parts of the cannabis plant that are not considered a narcotic drug is not subject to any specific authorization or requirement.
A. Are the rules different for medical vs. adult recreational use?
Yes, as stated above, recreational use of the parts of the plant considered a narcotic drug is not permitted, while medical use is subject to authorization by AEMPS.
B. Are retail sales of any cannabis products restricted to specific retail channels? E.g., medical dispensaries, government-owned stores, etc.
Provided the recreational use of the parts of the cannabis plant considered a narcotic drug is not permitted, only medicines containing cannabis are restricted to specific retail channels, as the retail sale of all medicines is limited to authorized pharmacies.
C. Are there zoning restrictions on where medical, wellness, or adult-use (recreational) outlets can be located? Applicable to all cannabis products?
There are no restrictions. The recreational use of the parts of the cannabis plant considered a narcotic drug is prohibited, and the therapeutic use of cannabis (not related to medicines) is not regulated.
7. What import and export is allowed in your jurisdiction?
A. Are there restrictions in relation to the countries of origin, i.e. which countries of origin are permitted?
To import cannabis seeds, documentation must be provided proving their licit origin. There are no restrictions on their specific geographic origin. However, the seeds imported from countries that are not part of the EU must correspond to species for which the production procedures and seed requirements are equivalent to those applicable in he EU.2
B. Please describe restrictions on the import of cannabis seeds.
Cannabis seeds are expressly excluded from the definition of narcotic drug; there is no restriction on importing cannabis seeds and no authorization is required.
8. Does your region distinguish between different types of cannabis products? (E.g., high or low concentrations of
THC.)
All distinctions are related to certain parts of the cannabis plant being considered a narcotic drug, and other parts not being a considered a narcotic drug, as explained above.
9. Are there legal requirements on cannabidiol (CBD) products (without THC)?
All specific legal requirements refer to the parts of the plant considered a narcotic drug. For products made using the parts of the cannabis plant not considered a narcotic drug, there are no specific requirements due to the fact that they may incorporate cannabidiol.
IV. Patients and prescriptions
10. What specific medical conditions, if any, are recognized for treatment with cannabis?
The therapeutic use of cannabis (not related to its incorporation into medicines) is not regulated in Spain. Only one medicine containing cannabis has been authorized in Spain, for the treatment of moderate or severe spasticity due to multiple sclerosis (“MS”) in patients who have not responded adequately to other anti-spasticity medications and have shown clinically significant improvement in spasticity-related symptoms during the treatment’s initial trial period.
11. Is there a licensed practitioner requirement in order to prescribe cannabis for medical purposes?
This question depends on the type of product:
(i) Only medical practitioners can prescribe medicines containing cannabis (as well as any other kind of medicine).
(ii) There are no special requirements for any other products containing cannabis whose use is permitted according to section 6 above.3.
12. Are there patient registration or cardholder requirements?
No. The therapeutic use of cannabis, other than its incorporation as an active substance in a medicine, has not been regulated yet, and for the only medicine authorized in Spain a valid prescription issued by a doctor is required.
2 See Order ARM/3372/2010 of December 27, passing the Technical Regulation of Control and Certification of Seeds of Textile Plants.
3 Those based on the parts of the cannabis plant not considered a narcotic drug.
V. Special requirements
13. Does your jurisdiction require any recordkeeping from seed planting to the time of end user sale? For all cannabis products?
All companies authorized to cultivate cannabis, incorporating the active narcotic substance, must keep accurate records of their production.
Also, all companies authorized to import, acquire, store, transit or export narcotic drugs must keep accurate records of the volumes they are handling.
14. Are special taxes imposed? On what and when?
Only products for recreational use (smoking) made with the parts of the plant not considered a narcotic drug could be subject to the excise duties on tobacco products.
VI. Risks and enforcement
All activities entailing the cultivation, production, import, acquisition, storage, transit or export of narcotic drugs contravening the applicable regulations or carried out without the corresponding authorizations will be considered illegal, under article 15 of Act 17/1967, which states that:
“All operations of cultivation, acquisition, alienation, import, exportation, deposit, storage, transport, distribution and trafficking of narcotic substances that do not comply with the provisions of this Act or with nonperformance of its prescripts will be considered traffic.”
Illegal traffic of narcotic drugs may constitute a crime:
(i) A criminal offense against public health under article 368 of the Spanish Criminal Code, which reads: “those who carry out acts of cultivation, preparation or trafficking, or who otherwise favor or facilitate the unlawful consumption of toxic drugs, narcotics or psychotropic substances, or who possess them for those purposes, will be punished with imprisonment from three to six years and a fine of one to three times the value of the drug the offense concerns, if they are substances or products that cause serious damage to health, and of imprisonment from one to three years and a fine from one to two times the amount in the remaining cases.”
(ii) Or at least an administrative infringement, which can be penalized in two ways:
- Under articles 32 and 33 of Act 17/1967, which states that all actions or omissions contrary to the effectiveness of the administrative norms passed by administrative and governmental bodies under the provisions of this Act (specifically non-compliance with the formalities established in the Act or the non-existence of mandatory declarations or controls) will constitute administrative infringements. These infringements may be sanctioned with fines up to EUR 3,005.06, the revocation of all authorizations or licenses granted, early termination of any public procurement agreements awarded, the closure of the facilities, and disqualification from developing any activity related to producing, manufacturing and trafficking narcotic drugs.
- Under sections 16 and 18 of article 36 of Act 4/2015, the following is a serious offense: ”...the illicit consumption or possession of poisonous, narcotic drugs or psychotropic substances, even if they were not destined for trafficking, in places, routes, public establishments or collective transports, as well as the abandonment of the instruments or other effects used for such consumption or possession in these places” and also “the execution of acts of illegal cultivation of narcotic drugs in visible locations.”
These offenses are sanctioned with fines up to EUR 30,000, the seizure of the products, the temporary suspension of all granted licenses and authorizations for up to six months and the temporary closure of the facilities for up to six months.
*Cuatrecasas
